Out-of-Hospital Non-Invasive Ventilation for Patients With Acute Respiratory Failure

Not Applicable

Completed

• Conditions: Respiratory Insufficiency; Respiratory Failure
• Interventions: Procedure: Non-invasive-ventilation; Procedure: conventional treatment

• Registration Number: NCT00885898
• Lead Sponsor: University of Göttingen

Brief Summary

In the past, patients suffering from acute respiratory failure had to be treated with Oxygen and specific medication, or - if this had not been sufficient - had to be anesthesized and had to undergo endotracheal intubation for invasive ventilation. Nowadays, since emergency ventilators are available that can be used for non-invasive ventilation, the purpose of this study is to investigate if non-invasive ventilation is safe, feasible and effective for the treatment of acute respiratory failure and if less patients will need to be intubated out-of-hospital as well as in the further course.

Detailed Description

Single center, prospective, randomized, intention-to-treat clinical trial. The study has been performed within a two tier EMS system of a major city. Prehospital emergency physicians are on scene in every patient enrolled to the study.

Patients with acute respiratory failure (SaO2 \< 90%, respiratory rate \> 20/min) were enrolled to the study using envelopes for randomisation for either "conventional" (O2 + medication) or "NIV." Vital signs have been documented as well as venous blood gases have been taken every 10 minutes after treatment has been started.

Primary endpoints are 28-day mortality, hospital-, ICU- and respirator-days, SAPS, SOFA II and complications. Secondary endpoints are out-of-hospital incidence of invasive ventilation, effect on SpO2, CO2, respiratory rate, heart rate and blood pressure.

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2007-01
• Status Verified: 2009-04
• Study Completion: 2009-04
• Study First Submitted: 2009-04-20
• Study First Submitted QC: 2009-04-21
• Last Update Submitted: 2009-04-21
• Study First Posted: 2009-04-22
• Last Update Posted: 2009-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• acute respiratory failure
• at least 18 years old
• cooperative

Exclusion Criteria

• cardiac arrest
• respiratory arrest
• unconscious
• uncontrollable agitation
• less than 18 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Non-invasive-ventilation	"Non-invasive ventilation"
2	conventional treatment	"Conventional"

Primary Outcome Measures

Name	Time	Method
28-day-mortality, ICU-days, respirator-days, SAPS, SOFA II, complications	30 days after enrollment

Secondary Outcome Measures

Name	Time	Method
out-of-hospital incidence of invasive ventilation, effect on SpO2, CO2, respiratory rate, heart rate and blood pressure	30 days after enrollment

Trial Locations

Locations (1)

EMS; 🇩🇪 Goettingen, Lower Saxony, Germany